BIO
Yoshitaka Ando
Senior Director, Head of Regulatory & Access, Japan
Yoshitaka Ando has over 28 years of experience in drug development across pharmaceutical companies and global CROs. His expertise spans the entire drug development lifecycle, from early-stage research to commercialization, including translational studies and observational study to obtain RWE.
For the past 8 years, he’s focused on consulting for overseas biotech companies entering the Japanese market, offering support in PMDA consultations, KOL interview and management, clinical study conduct, and JNDA submissions. His diverse background includes 14 years in biotechnology and 3 years as Principal Administrator at the OECD's Biotechnology Unit.
Ando-san holds a degree from the University of Tokyo in Applied Microbiology and EMBA from Harvard Business School, combining scientific knowledge with business acumen in his leadership role.